Shuttle Pharmaceuticals Hits Milestone in Patient Enrollment for Phase 2 Clinical Trial

Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ:SHPH) recently announced reaching a significant milestone in patient enrollment for its Phase 2 Clinical Trial of Ropidoxuridine, a potential treatment for patients diagnosed with glioblastoma. The company disclosed this development in a press release issued on January 21, 2025.

The Phase 2 trial aims to randomize 40 patients into two varying dose levels, with 20 individuals receiving 1,200 mg/day and the other 20 receiving 960 mg/day. This randomization process seeks to determine the optimal dosage for glioblastoma patients. Following the identification of the optimal dose, an additional 14 patients will be enrolled to establish statistical significance in endpoint survival compared to historical controls. The trial specifically targets patients with IDH wild-type, methylation negative glioblastoma, a group that currently has limited treatment options beyond radiation therapy, with less than half surviving beyond 12 months post-diagnosis.

Ropidoxuridine (IPdR) represents the leading candidate radiation sensitizer for use in conjunction with radiation therapy to address glioblastoma, a fatal form of brain cancer without a known cure. Shuttle Pharmaceuticals obtained Orphan Drug Designation from the FDA, potentially granting the company marketing exclusivity upon receiving FDA approval for treating this condition.

The Phase 2 trial is actively conducted across several locations, including Georgetown University Medical Center, Allegheny Health Network Cancer Institute, UNC Medical Center, UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, and Miami Cancer Institute under Baptist Health South Florida.

Expressing optimism towards the progress made, Anatoly Dritschilo, M.D., CEO and Chairman of Shuttle Pharmaceuticals, stated, “Enrollment into the trial is ahead of our expectations. I am grateful to the teams at each of these nationally recognized cancer centers for their participation in the trial as we look to develop radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.”

The company’s efforts underscore an ongoing commitment to improving outcomes for cancer patients undergoing radiation therapy. The Phase 2 study (NCT06359379) details can be accessed on clinicaltrials.gov.

Shuttle Pharmaceuticals, a specialty pharmaceutical company established in 2012, focuses on developing solutions to enhance the effectiveness of radiation therapy while minimizing its adverse effects on cancer patients. For more information about the company’s initiatives, visit shuttlepharma.com.

This announcement may contain forward-looking statements, reflecting management’s current views and expectations. These statements involve certain risks, uncertainties, and assumptions that could lead to divergent outcomes. Interested parties are advised to refer to Shuttle Pharmaceuticals’ filings with the SEC for a comprehensive understanding of the factors affecting the company’s performance.

Contact:
Anatoly Dritschilo, M.D., CEO
Shuttle Pharmaceuticals Holdings, Inc.
Phone: 240-403-4212
Email: [email protected]

Investor Contacts:
Lytham Partners, LLC
Robert Blum
Phone: 602-889-9700
Email: [email protected]

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Shuttle Pharmaceuticals’s 8K filing here.

Shuttle Pharmaceuticals Company Profile

Shuttle Pharmaceuticals Holdings, Inc, a clinical stage pharmaceutical company, develops novel therapies to cure cancers. It develops Ropidoxuridine, an oral halogenated pyrimidine to treat patients with brain tumors and sarcomas SP-1-161, an HDAC inhibitor that initiates the mutated in ataxia-telangiectasia response pathway for radiation sensitizing cancer cells and protecting normal cells; SP-2-225, a pre-clinical class IIb that effects on the regulation of the immune system; and SP-1-303, a pre-clinical selective Class I HDAC for the treatment of ER positive cancers .